ME00930B - Progesterone for the prevention of preterm birth - Google Patents

Progesterone for the prevention of preterm birth

Info

Publication number
ME00930B
ME00930B MEP-2009-265A MEP26509A ME00930B ME 00930 B ME00930 B ME 00930B ME P26509 A MEP26509 A ME P26509A ME 00930 B ME00930 B ME 00930B
Authority
ME
Montenegro
Prior art keywords
progesterone
drug according
cervix
pregnancy
administration
Prior art date
Application number
MEP-2009-265A
Other languages
French (fr)
Unknown language (me)
Inventor
George Creasy
Brien Jr John M O'
Emily A Defranco
Kenneth N Muse
Original Assignee
Columbia Laboratories Bermuda Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39301249&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME00930(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Columbia Laboratories Bermuda Ltd filed Critical Columbia Laboratories Bermuda Ltd
Publication of ME00930B publication Critical patent/ME00930B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/06Antiabortive agents; Labour repressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Postupak  za  lečenje   ili  prevencjju  spontanog  prevremenog   porođaja   kod  trudnica  i poboljšavanje neonatalnog morbiditeta i smrtnosti. Postupak obuhvata davanje trudnicama efikasne  količine  progesterna  dovoljne da produži  trudnoću  minimiziranjem skraćivanja  ili  otvaranja  njihovog  grlića. Tretman  i profilaksa progesteronom  trudnica koje  imaju  simpotme   kratkog   grlića  je  klinički  dokazano   da  povećava   neonatalno zdravlje.A procedure for treating or preventing spontaneous preterm birth in pregnant women and improving neonatal morbidity and mortality. The procedure involves giving pregnant women an effective amount of progesterone sufficient to prolong their pregnancy by minimizing the shortening or opening of their cervix. Treatment and prophylaxis with progesterone of pregnant women with symptoms of short cervix has been clinically proven to increase neonatal health.

Claims (29)

1. Lek koji sadrži progesteron za upotrebu u lečenju i sprečavanju početka prevremenih trudova i naknadnog porođaja kod trudnica sa kratkim grlićem od oko 1.0 cm do oko 3.5 cm, gde je progesteron prisutan u količini koja je dovoljna da minimizira skraćenje grlića.1. A medicament containing progesterone for use in treating and preventing the onset of preterm labor and subsequent labor in pregnant women with a short cervix of about 1.0 cm to about 3.5 cm, wherein progesterone is present in an amount sufficient to minimize shortening of the cervix. 2. Lek prema zahtevu l, koji je u obliku vaginalnog gela, vaginalne supozitorije, vaginalne kreme ili vaginalnog čvrstog doznog oblika.2. The drug according to claim 1, which is in the form of a vaginal gel, vaginal suppository, vaginal cream or vaginal solid dosage form. 3. Lek prema zahtevu l, koji je formulisan za davanje intramuskulamo, oralno, rektalno, subkutanozno, vaginalno, intradermalno, lokalno, intranazalno, intraperitonealno, intraartikulamo, intraventrikulamo, intratekalno, intravaginalno ili intravenskim putem.3. The drug according to claim 1, which is formulated for administration intramuscularly, orally, rectally, subcutaneously, vaginally, intradermally, topically, intranasally, intraperitoneally, intraarticularly, intraventricularly, intrathecally, intravaginally or intravenously. 4. Lek prema bilo kom od prethodnih zahteva, u kojima je progesteron prirodni progesteron ili metabolit progesterona.4. A medicament according to any one of the preceding claims, wherein the progesterone is naturally occurring progesterone or a metabolite of progesterone. 5. Lek prema bilo kom od prethodnih zahteva, u kome progesteron obuhvata sintetički progesteron izabran od 17-alfa-hidroksiprogesteron kaproata, medroksiprogesteron acetata, noretindron, noretindron acetata, noretindron etantata, dezogestrela, levonorgestrel, linesterol, etinodiol diacetata, norgestrela, norgestimata, noretinodrela, gestodena, drospirenona, trimegestrona, levodesogestrela, gestodina, nesterona, etonogestrela i derivata 19-nor-testosterona.5. The drug according to any of the preceding claims, in which the progesterone comprises a synthetic progesterone selected from 17-alpha-hydroxyprogesterone caproate, medroxyprogesterone acetate, norethindrone, norethindrone acetate, norethindrone ethanate, desogestrel, levonorgestrel, linesterol, ethynodiol diacetate, norgestrel, norgestimate, noretinodrel , gestodene, drospirenone, trimegestrone, levodesogestrel, gestodyne, nesterone, etonogestrel and 19-nor-testosterone derivatives. 6. Lek prema bilo kom od prethodnih zahteva za dnevno davanje.6. Medicine according to any of the previous requirements for daily administration. 7. Lek prema bilo kom od prethodnih zahteva, za davanje od oko 18. do 22. nedelje trudnoće do oko 37. nedelje trudnoće.7. A drug according to any of the preceding claims, for administration from about 18 to 22 weeks of pregnancy to about 37 weeks of pregnancy. 8. Lek prema zahtevu 6, za davanje u toku perioda od oko 14 do 19 nedelja.8. The drug according to claim 6, for administration during a period of about 14 to 19 weeks. 9. Lek prema zahtevu 6, za davanje od oko 16. nedelje trudnoće do oko 37. nedelje trudnoće.9. The drug according to claim 6, for administration from about the 16th week of pregnancy to about the 37th week of pregnancy. 10. Lek prema zahtevu 6, za davanje u toku perioda od oko 21 nedelje.10. The drug according to claim 6, to be administered over a period of about 21 weeks. 11. Lek prema zahtevu 6, za davanje od vremena pozitivnog testa trudnoće do oko 37. nedelje trudnoće.11. The drug according to claim 6, to be administered from the time of a positive pregnancy test until about the 37th week of pregnancy. 12. Lek prema zahtevu 6, za davanje od oko 2. do 4. nedelje trudnoće.12. The drug according to claim 6, for administration from about the 2nd to the 4th week of pregnancy. 13. Lek prema zahtevu 6 za davanje u toku 33 do 35 nedelja.13. Medicine according to claim 6 for administration during 33 to 35 weeks. 14. Lek prema zahtevu 6 za davanje u zavisnosti od vremena trudnoće na početku tretmana i dana porođaja.14. Medicine according to claim 6 for administration depending on the time of pregnancy at the beginning of the treatment and the day of delivery. 15. Lek prema bilo kom od prethodnih zahteva, koji je formulisan za davanje od oko 45 mg do oko 800 mg progesterona.15. A medicament according to any one of the preceding claims, which is formulated to administer from about 45 mg to about 800 mg of progesterone. 16. Lek prema bilo kom od prethodnih zahteva, koji je u obliku ili sadrži sistem za davanje leka koji sadrži progesteron, vodorastvoran i umetženi polimer polikarboksilne kiseline koji bubri u vodi i bar jedno pomoćno sredstvo.16. A drug according to any of the preceding claims, which is in the form of or contains a drug delivery system containing progesterone, a water-soluble and intercalated water-swellable polycarboxylic acid polymer, and at least one excipient. 17. Lek prema bilo kom od prethodnih zahteva, gde grlić trudnice ima dužinu veću od oko 1.0 cm.17. A drug according to any of the preceding claims, wherein the cervix of the pregnant woman has a length greater than about 1.0 cm. 18. Lek prema bilo kom od prethodnih zatheva, gde grlić trudnice ima dužinu od oko 1.0 cm do oko 3.0 cm.18. The drug according to any one of the preceding claims, wherein the cervix of the pregnant woman has a length of about 1.0 cm to about 3.0 cm. 19. Lek prema bilo kom od prethodnih zahteva, gde grlić trudnice ima dužinu manju ili jednaku oko 3.0 cm.19. A drug according to any of the preceding claims, wherein the cervix of the pregnant woman has a length less than or equal to about 3.0 cm. 20. Lek prema bilo kom od prethodnih zahteva, gde progesteron obuhvata i prirodni progesteron i 17-alfa-hidroksiprogesteron.20. A drug according to any one of the preceding claims, wherein the progesterone comprises both natural progesterone and 17-alpha-hydroxyprogesterone. 21. Lek prema bilo kom od prethodnih zahteva, koji je formulisan za davanje doze od oko 90 mg progesterona i gde je progesteron prirodni progesteron.21. A medicament according to any one of the preceding claims, which is formulated to deliver a dose of about 90 mg of progesterone and wherein the progesterone is naturally occurring progesterone. 22. Lek prema bilo kom od prethodnih zahteva, koji je za upotrebu u poboljšanju neonatalnog morbiditeta i smrtnosti kod prevremene novorođenčadi, očekivane ili naknadno rođene, od trudnica sa kratkim grlićem od oko 1.0 cm do oko 3.5 cm.22. A medicament according to any one of the preceding claims, for use in improving neonatal morbidity and mortality in premature infants, expected or postterm, of pregnant women with a short cervix of about 1.0 cm to about 3.5 cm. 23. Lek prema bilo kom od prethodnih zahteva, koji je za davanje u kombinaciji sa jednim ili više jedinjenja za lečenje ili profilaksu prevremenog porođaja.23. A drug according to any one of the preceding claims, which is for administration in combination with one or more compounds for the treatment or prophylaxis of preterm labor. 24. Lek prema bilo kom od zahteva l do 22, koji je za davanje u kombinaciji sa kliničkim postupkom za lečenje ili profilasku prevremenog porođaja.24. The drug according to any one of claims 1 to 22, which is to be administered in combination with a clinical procedure for the treatment or prophylaxis of preterm labor. 25. Upotreba progesterona u proizvodnji leka za lečenje ili sprečavanje početka trudova i naknadnog prevremenog porođaja kod trudnica sa kratkim grlićem od oko 1.0 cm do oko 3.5 cm, gde je progesteron korišćen u količini koje je dovoljna da minimizira skraćenje grlića.25. Use of progesterone in the manufacture of a medicament for treating or preventing the onset of labor and subsequent premature labor in pregnant women with a short cervix of about 1.0 cm to about 3.5 cm, wherein the progesterone is used in an amount sufficient to minimize shortening of the cervix. 26. Uređaj za davanje leka koji je konstruisan za umetanje u vaginu, koji sadrži lek prema bilo kom od zahteva l do 22.26. A drug delivery device designed to be inserted into the vagina, containing a drug according to any one of claims 1 to 22. 27. Uređaj za davanje prema zahtevu 26, pri čemu je uređaj cervikalni prsten, ili uređaj sadrži cervikalni prsten.27. The delivery device of claim 26, wherein the device is a cervical ring, or the device comprises a cervical ring. 28. Postupak za lečenje ili sprečavanje početka prevremenih trudova i naknadnog prevremenog porođaja kod trudnica sa kratkim grlićem od oko 1.0 cm do oko 3.5 cm, koji se sastoji od davanja ženama progesterona u količini dovoljnoj da smanji skraćenje grlića.28. A procedure for treating or preventing the onset of preterm labor and subsequent preterm birth in pregnant women with a short cervix of about 1.0 cm to about 3.5 cm, which consists of giving the woman progesterone in an amount sufficient to reduce the shortening of the cervix. 29. Postupak poboljšavanja neonatalnog morbiditeta i smrtnosti kod prevremeno rođene odojčadi koji se sastoji od davanja trudnicama sa kratkim grlićem od oko 1.0 cm do oko 3.5 cm progesterona u količni dovoljnoj da smanji ili odloži dalje skraćenje grlića ili produži trudnoću.29. A method of improving neonatal morbidity and mortality in premature infants comprising administering to pregnant women with a short cervix of about 1.0 cm to about 3.5 cm progesterone in a quantity sufficient to reduce or delay further shortening of the cervix or prolong the pregnancy.
MEP-2009-265A 2007-02-06 2008-02-05 Progesterone for the prevention of preterm birth ME00930B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US88848007P 2007-02-06 2007-02-06
US97366707P 2007-09-19 2007-09-19
PCT/GB2008/000397 WO2008096122A2 (en) 2007-02-06 2008-02-05 Progesterone for the prevention of preterm birth

Publications (1)

Publication Number Publication Date
ME00930B true ME00930B (en) 2012-03-20

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ID=39301249

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Application Number Title Priority Date Filing Date
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US (2) US8828981B2 (en)
EP (1) EP2117554B1 (en)
JP (2) JP5580601B2 (en)
KR (1) KR101546101B1 (en)
AR (1) AR065179A1 (en)
AU (1) AU2008212724A1 (en)
BR (1) BRPI0807203A2 (en)
CA (1) CA2677354C (en)
CL (1) CL2008000375A1 (en)
CO (1) CO6220941A2 (en)
CR (1) CR10985A (en)
ES (1) ES2596803T3 (en)
GE (1) GEP20135727B (en)
IL (1) IL200272A (en)
MA (1) MA31200B1 (en)
ME (1) ME00930B (en)
MX (1) MX2009008409A (en)
MY (1) MY184866A (en)
NZ (1) NZ579114A (en)
PE (1) PE20081738A1 (en)
RU (1) RU2524617C2 (en)
TW (1) TWI471135B (en)
WO (1) WO2008096122A2 (en)

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